Browse Drug Recalls
1,152 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 1,152 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Drug Safety Recalls
Browse 1,152 FDA drug recalls in 2021.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 15, 2021 | xigduo XR (dapagliflozin/metformin HCl extended-release) tablets 5 mg/1000 mg... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | DEXAMETH SOD PHOS 0.1% 5ML; NDC/UPC 24208072002; RX; DROPS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | TRELEGY ELLIPTA (FLUTICASONE FUROATE, UMEDIDINIUM AND VILANTEROL INHALATION P... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | LITHIUM CARB 150MG 100; NDC/UPC 54252625; RX; CAPSULES | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | FENOFIBRATE CAPSULES, UPS 67MG 100 CAPSULES NDC/UPC 27241-118-04; RX; CAPSULES | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | METHOCARBAMOL 500MG 500; NDC/UPC 71093014005; RX; TABLETS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | VITAMIN D3 25MCG 90 TABLETS; NDC/UPC 880681168004; OTC; TABLETS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | Metoprolol Tartrate and Hydrochlorothiazide Tablets, USP 50 mg/25 mg 100 Tabl... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | Methotrexate Injection, USP 50 mg/2mL (25 mg/mL) 5 x 2mL Single-Dose Vials, S... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | Brilinta ticagrelar tablets 60 mg 60 tablets Rx only NDC 0186-0776-60 Mfd. fo... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | LOTEMAX SM (loteprednol etabonate ophthalmic gel) 0.38% 5GM; NDC/UPC 24208-05... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | NEOMYCIN SULF TABLETS, USP, 500mg, 100-count bottle, Rx Only, Distributed by:... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | Spiriva HandiHaler (tiotropium bromide inhalation powder) For Oral Inhalation... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | Tylenol Acetaminophen Pain Regular Strength Liquid Gels Pain Reliever Fever R... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | PRAVACHOL 40MG 90; NDC/UPC 3519410; RX; TABLETS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | Orilissa elagolix tablets 150 mg per tablet equivalent to 155.2 mg elagolix s... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | edarbyclor Azilsartan Medoxomil and Chlorthalidone Tablets 40 mg*/12.5 mg 30 ... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | Belsomra (suvorexant) tablets 10 mg Each tablet contains 10 mg suvorexant. T... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | Synjardy XR (empagliflozin and metformin) hydrochloride extended-release) Tab... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | Verapamil Hydrochloride Extended-Release Tablets USP 120 mg Rx Only NDC 68462... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | HALOPERIDOL TABLETS 20mg, USP, 100-count bottle, Rx Only Distributed by: Ushe... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | BENICAR 40MG 30; NDC/UPC 65597010430; RX; TABLETS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | ZOLPIDEM TARTRATE SUBLINGUAL TABLET 3.5 MG 30 UNIT DOSE POUCHES; NDC/UPC 498... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | Jentadueto XR (linagliptin and metformin hydrochloride extended-release) Tabl... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | FLOVENT DISKUS 100MCG 60; NDC/UPC 173060202; RX; INHALER MEDICAL INTERNAL - M... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | ASMANEX TWST 220MCG 60INH PWD; NDC/UPC 85134102; RX; INHALER MEDICAL INTERNAL... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | Atropine Sulfate Ophthalmic Solution, USP 1% For Topical Application To The E... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | THERAPEUTIC M 130; NDC/UPC 740985223680; OTC; TABLETS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | Ferrous Sulfate 75 mg (equivalent to 15 mg Iron) Per 1.0 mL Alcohol 0.2% v/v ... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | Desvenlafaxine Extended-Release Tablets 25 mg 30 Tablets Rx Only NDC 0591-406... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | HYDROCORTISONE ACET 30MG 12; RX; SUPPOSITORY,Rx Only, Distributed by: Perrigo... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | Chantix (varenicline) Tablets Starting Pack Contains: 1 Starting Week (0.5 mg... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | AcetaZOLAMIDE Tablets, USP 125 mg 100 Tablets Rx only NDC 23155-287-01 Manufa... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | Corgard (nadolol tablets, USP) 40 mg 100 Tablets Rx only NDC 27505-101-01 Dis... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | Nitrofurantoin Macrocrystals Capsules 25 mg 100 Capsules Rx Only NDC 47781-30... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | PHENTERMINE HCL 30MG 100 C4; NDC/UPC 10702002801; RX; CAPSULES | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | Nadolol Tablets, USP 40 mg 100 Tablets Rx Only NDC 69097-868-07 Manufactured ... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | Enalapril Maleate Tablets, USP 2.5 mg 100 tablets Rx only Distributed by: Car... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | Meloxicam Tablets, USP 7.5 mg 100 Tablets Rx Only NDC 69097-158-07 Manufactur... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | ENOXAPARIN DOFIUM INJRVYION, UPD 150MG/1ML 10X1ML SINGLE DOSE SYRINGES; NDC/U... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | Steglatro (ertugliflozin) tablets 15 mg 30 Tablets Rx only NDC 0006-5364-03 M... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | DIBUCAINE TOPICAL ANESTHETIC 1% HEMORRHOIDAL OINTMENT 28GM ; NDC/UPC 0536-12... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | VIMPAT(lacosamide) Tablets ,100 mg, 60-count bottle; Rx Only, Manufactured fo... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | Narcan (naloxone HCl) Nasal Spray 4 mg Two Pack This box contains two (2) 4-m... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | Trelegy Ellipta (fluticasone furoate, umeclidinium, and vilanterol inhalation... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | Auryxia (ferric citrate) tablets 210 mg* 200 Tablets Rx Only NDC 59922-631-01... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | Benztropine Mesylate Tablets, USP in all pack sizes, styles and strengths Man... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | Levalbuterol tartrate HFA Inhalation Aerosol 45 mcg/actuation 200 Metered Inh... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | Belbuca (buprenorphine hydrochloride) buccal film 600 mcg 60 pouches containi... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | Sulindac Tablets, USP, 200mg 100-count bottles, Rx Only, Manufactured by: Epi... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
Frequently Asked Questions
When a drug safety issue is identified — through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks — the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.
The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.
Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.